Nutritional status: copper deficiency
Nutritional status: copper deficiency
Did you know that copper is an essential trace mineral present in all tissues? It works with iron to help the body form red blood cells. It also helps keep the blood vessels, nerves, immune system and bones healthy while also aiding in iron absorption. In rare situations, copper deficiency can occur and lead to anaemia and osteoporosis.
Symptoms of copper deficiency include:
- Fatigue & weakness as cells use copper to generate ATP, the body’s main source of energy. This means that copper deficiency could affect your energy levels.
- Frequent sickness as copper plays an important role in maintaining a healthy immune system.
- Weak and brittle bones as copper is involved in the processes that create cross-links inside your bones. These cross-links ensure bones are healthy and strong.
- Problems with memory and learning as copper plays an important role in brain function and development.
Sensitivity to cold as copper, along with minerals like zinc, help maintain optimal thyroid gland function. Low thyroid levels can make you feel colder more easily.
There are many foods that are high in copper. These include leafy greens, including turnip, greens, spinach, kale and mustard greens. Asparagus and summer squash are two other excellent sources of copper while legumes, whole grains, nuts and seeds are also good sources of the substance.
Randox Reagents, RX and QC are helping to diagnose copper deficiency at the earliest possible stage. The Randox copper assay is used to measure the levels of copper in the blood in order to determine copper toxicity. Combining this with the Randox zinc assay can aid in identifying the cause of liver damage in a patient, leading to correct treatment and recovery.
Find out more about how Randox is helping to diagnose nutritional status and deficiencies here: https://www.randox.com/nutritional-status/
How Randox is helping to diagnose nutritional status
At Randox, we’re dedicated to improving health worldwide and are consistently trying to break our own innovative records. Throughout the month of July, we’ll be introducing you to how we’re helping to diagnose nutritional deficiencies and define individual nutritional status among patients.
Zinc
Randox Reagents
Randox Reagents have the highest quality reagents on the market and a test menu comprising of over 113 assays. Unique to Randox is the zinc assay which is important in the diagnosis of kidney and liver damage.
Our zinc assay can be used to measure the levels of zinc in a patient’s urine providing insight into the levels of zinc in the body. This, combined with our copper assay, can aid in identifying the cause of liver damage in a patient, leading to correct treatment and recovery.
The RX series
The RX series offers the most comprehensive testing profile for assessing nutritional status to identify any nutritional deficiencies or any other nutritional issues within an individual.
The RX series zinc test can identify a zinc deficiency in an individual which is often a result of a low dietary intake and can lead to many problems including impaired immune and cognitive functions, kidney disease and diabetes.
Randox Quality Control
World-leading diagnostics would be nothing without world-leading quality control materials to ensure consistency and accuracy across all results. The Randox Acusera Liquid Chemistry Premium Plus control is the most comprehensive chemistry control available.
Stay tuned over the course of the month as we highlight how we’re helping in the fight against nutrient deficiencies.
Women’s Health: Testing for CVD
Did you know that cardiovascular disease is the most common cause of death in women? Cardiovascular disease, or CVD, accounts for 27% of all female deaths. That’s much higher than what is commonly thought to be the biggest killer of women – breast cancer. At Randox, we’re using our innovative technology to diagnose CVD cases as early as possible so appropriate treatment can be sought.
The Randox clinical product range offers a wide range of products to combat heart issues including the RX series extensive cardiac testing panel, reagents such as H-FABP, Adiponectin an TxB Cardio and an extensive cardiac QC range available in both liquid & lyophilised format.
You can find out more about how Randox is helping to diagnose women’s health issues, such as CVD, here.
What is CVD?
Cardiovascular disease (CVD) is a general terms for conditions that affect the heart and/or blood vessels. It is usually associated with the build-up of fatty deposits in the arteries and an increased risk of blood clots.
CVD is one of the main causes of death and disability in the UK but can often largely be prevented with a healthy lifestyle.
Types of CVD
Coronary heart disease
This occurs when the flow of oxygen-rich blood to the heart muscle is blocked or reduced
Stroke
A stroke is where the blood supply to part of the brain is cut off, which can cause brain damage and possibly death. A transient ischaemic attack (also called a TIA or “mini-stroke”) is similar, but the blood flow to the brain is only temporarily disrupted.
Causes of CVD
The exact cause of CVD isn’t clear, but there are lots risk factors that can increase your risk of getting it. The more risk factors you have, the greater your chances of developing CVD. Risk factors include:
- High blood pressure
- Smoking
- High cholesterol
- Diabetes
- Inactivity
- Being overweight or obese
- Family history of CVD
- Ethnic background
Preventing CVD
- Stop smoking
- Have a balanced diet
- Exercise regularly
- Maintain a healthy weight
- Cut down alcohol consumption
How is Randox helping to detect CVD?
Randox has developed the RX series of clinical chemistry analysers for superior semi-automated and fully automated testing. The RX series extensive dedicated test menu goes beyond routine testing and has many unique and high-performance tests available. Our range of tests covers many tests for the diagnosis and monitoring of cardiac diseases.
Cardiac Panel
| Cholesterol | CRP Full Range(0.3-160mg/l) | Direct LDL Cholesterol | sLDL |
| CK-MB | CRP High Sensitivity | Heart-Type Fatty Acid Binding Protein (H-FABP) | Triglycerides |
| CK-NAC | Digoxin | Lipoprotein(a) | TxB Cardio |
| CRP | Direct HDL Cholesterol | Myoglobin | Adiponectin |
Our world leading test menu of high quality reagents guarantees excellence in patient care ensuring unrivalled precision and accuracy reducing costly test re-runs or misdiagnosis and offering complete confidence in results.
The RX series clinical chemistry analysers provide laboratories with a robust and smart solution ensuring you maintain a consistent workflow and can provide accurate results first time, every time. Offering excellent customer support services, our trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument.
For more information visit: https://www.randox.com/clinical-chemistry-analysers/
Did you know that cardiovascular disease is the most common cause of death in women? Cardiovascular disease, or CVD, accounts for 27% of all female deaths. That’s much higher than what is commonly thought to be the biggest killer of women – breast cancer. At Randox, we’re using our innovative technology to diagnose CVD cases as early as possible so appropriate treatment can be sought.
The Randox clinical product range offers a wide range of products to combat heart issues including the RX series extensive cardiac testing panel, reagents such as H-FABP, Adiponectin an TxB Cardio and an extensive cardiac QC range available in both liquid & lyophilised format.
You can find out more about how Randox is helping to diagnose women’s health issues, such as CVD, here.
What is CVD?
Cardiovascular disease (CVD) is a general terms for conditions that affect the heart and/or blood vessels. It is usually associated with the build-up of fatty deposits in the arteries and an increased risk of blood clots.
CVD is one of the main causes of death and disability in the UK but can often largely be prevented with a healthy lifestyle.
Types of CVD
Coronary heart disease
This occurs when the flow of oxygen-rich blood to the heart muscle is blocked or reduced
Stroke
A stroke is where the blood supply to part of the brain is cut off, which can cause brain damage and possibly death. A transient ischaemic attack (also called a TIA or “mini-stroke”) is similar, but the blood flow to the brain is only temporarily disrupted.
Causes of CVD
The exact cause of CVD isn’t clear, but there are lots risk factors that can increase your risk of getting it. The more risk factors you have, the greater your chances of developing CVD. Risk factors include:
- High blood pressure
- Smoking
- High cholesterol
- Diabetes
- Inactivity
- Being overweight or obese
- Family history of CVD
- Ethnic background
Preventing CVD
- Stop smoking
- Have a balanced diet
- Exercise regularly
- Maintain a healthy weight
- Cut down alcohol consumption
How is Randox helping to detect CVD?
Randox has developed the RX series of clinical chemistry analysers for superior semi-automated and fully automated testing. The RX series extensive dedicated test menu goes beyond routine testing and has many unique and high-performance tests available. Our range of tests covers many tests for the diagnosis and monitoring of cardiac diseases.
Cardiac Panel
| Cholesterol | CRP Full Range(0.3-160mg/l) | Direct LDL Cholesterol | sLDL |
| CK-MB | CRP High Sensitivity | Heart-Type Fatty Acid Binding Protein (H-FABP) | Triglycerides |
| CK-NAC | Digoxin | Lipoprotein(a) | TxB Cardio |
| CRP | Direct HDL Cholesterol | Myoglobin | Adiponectin |
Our world leading test menu of high quality reagents guarantees excellence in patient care ensuring unrivalled precision and accuracy reducing costly test re-runs or misdiagnosis and offering complete confidence in results.
The RX series clinical chemistry analysers provide laboratories with a robust and smart solution ensuring you maintain a consistent workflow and can provide accurate results first time, every time. Offering excellent customer support services, our trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument.
For more information visit: https://www.randox.com/clinical-chemistry-analysers/
June focus: Women’s Health
Randox is dedicated to improving health worldwide. Throughout the month of June we hope to highlight how the Randox clinical product range can ensure accurate and swift diagnosis and, by doing so, improve women’s health. We can do this by allowing for necessary steps to be taken post-diagnosis. A common-held misconception is that breast cancer is the biggest threat to a woman’s health, however, the biggest health risk to women statistically is heart disease which accounts for roughly 27% of female deaths. The Randox clinical product range offers a wide range of products to combat heart issues including the RX series extensive cardiac testing panel, reagents such as H-FABP, Adiponectin an TxB Cardio and an extensive cardiac QC range available in both liquid & lyophilised format.
Randox Reagents
Randox Reagents have the highest quality reagents on the market and a test menu comprising of over 118 assays covering over 100 disease markers. Several of these reagents will play a key role in diagnosis in women such as Randox’s Lipoprotein (a) – Lp(a) test, The Randox Lp(a) offers swift and accurate diagnosis of elevated circulation Lp(a) levels which is significant for women as they have an increased risk of CVD due to elevated levels of Lp(a). Several traditional CVD risk markers, including elevated LDL may be absent in some women, elevated Lp(a) levels may identify women at high risk of developing CVD.
RX Series
The RX series range of clinical chemistry analysers offers the most comprehensive testing profile for assessing health in males and females. Urinary tract infections are more commonly found in women and the RX series extensive renal function panel will provide clarity in terms of a woman’s urological health by testing for 19 separate analytes, including microalbumin. The RX series microalbumin test can detect very low levels of albumin in urine and if albumin is detected it can be an indicator of kidney injury and can result in irreversible damage. To view the full RX series test menu click here.
Quality Control
The Randox Acusera Maternal Screening quality control is the only commercially available control which covers all six analytes used during first and second trimester screening of Down’s syndrome and Spina Bifida. Instrument-specific target values and ranges are provided for AFP, Inhibin A, PAPP-A, β hCG, Total hCG and Unconjugated Estriol. The inclusion of PAPP-A and Inhibin A eliminates the need to purchase additional controls at extra expense.
RIQAS
The RIQAS Maternal Screening EQA programme is designed to monitor the performance of screening tests used during the first and second trimester of pregnancy to assess the risk of Down’s syndrome, Spina Bifida and Trisomy 18. 100% human serum ensures commutability while the lyophilised material allows for enhanced stability. Monthly reporting allows laboratories to become aware of issues and remedy them early.
Metabolism: how Randox is helping to diagnose metabolic conditions
Many people talk about their metabolism as if it is a muscle or organ they can somehow control. In reality, your metabolism refers to a series of chemical processes in each cell that turn the calories you eat into fuel to keep you alive.
Metabolism is the biochemical process of combining nutrients with oxygen to release the energy our bodies need to function. Your resting metabolic rate (RMR) is the number of calories your body burns to maintain vital body functions such as heart rate, brain function and breathing. RMR accounts for up to 75 percent of the calories you burn each day. Knowledge of your individual RMR is a critical piece of information to appropriately establish daily calorie needs.
The body’s major organs — the brain, liver, kidneys, and heart — account for about half of the energy burned at rest, while fat, the digestive system, and especially the body’s muscles account for the rest.
Did you know?
Approximately 20-25% of the world’s adult population have metabolic syndrome?
A common misconception surrounding metabolic health is that it refers solely to your weight, and if you are overweight you are considered to be unhealthy. But in actual fact this may not be entirely true. Good metabolism means that your body is in good overall health, which doesn’t account for just your weight! Common metabolic disorders include genetic metabolic disorders, diabetes and metabolic syndrome. Understanding and testing to see how well your metabolism is functioning is key to ensuring long lasting health.
Genetics
There are a number of genetic metabolic disorders caused by mutations of single genes. Examples of common disordersinclude Gaucher’s disease, hemochromatosis and cystic fibrosis. Gaucher’s disease is a genetic disorder that affects the body’s ability to break down fat that can accumulate in the liver/spleen and bone marrow. Hemochromatosis is a condition that is caused by the over-absorption and build-up of iron while cystic fibrosis is a metabolic disorder that appears as a result of a build-up of mucus in lungs/liver and intestines. Each of these metabolic disorders affect certain organs from functioning properly and therefore your overall healthiness.
Diabetes
Type 2 diabetes is one of the most common types of metabolic disorders in the world that is expected to affect 592 million people by 2035. It is characterised by high blood sugar, insulin resistance or a lack of insulin being produced by the pancreas. Insulin resistance occurs when the body isn’t able to use insulin the right way which increases blood glucose levels. Insulin is needed for cells to take in glucose (sugar) from the bloodstream and convert it into energy. Over time this lack of insulin can damage the organs in your body.
Metabolic Syndrome
Metabolic syndrome (also known as syndrome X, Reaven’s syndrome, and CHAOS) is not a disease but a collection of risk factors that affect your health; these include high blood pressure, high blood sugar/cholesterol and abdominal fat. Left untreated, these risk factors, together, can lead to long term serious problems including an increased risk of heart disease, stroke and developing type 2 diabetes.
Can you improve your metabolic health?
Yes! The good news is that if you discover that your metabolic health is not up to scratch you can improve it through a combination of diet, exercise and lifestyle adjustments such as:
- 30 minutes of moderate to intense exercise 5-7 times a week
- Low-dose aspirin to reduce your risk of stroke or heart attack
- Quit smoking
- Medication for blood pressure/cholesterol/ blood sugar
- Limit alcohol intake
- Eat a healthy balanced diet
Related Products
Randox has developed the RX series of clinical chemistry analysers for superior semi-automated and fully automated testing. The RX series extensive dedicated test menu goes beyond routine testing and has many unique and high-performance tests available. Our range of tests covers several parameters to assess your overall metabolic health.
Metabolic Health Profile
| Albumin | Chloride | Potassium |
| Alkaline Phosphatase | C02 Total | Sodium |
| ALT | Creatinine | Total Bilirubin |
| AST (GOT) | Glucose | Total Protein |
| Direct Bilirubin | Lactate | Urea |
| Calcium |
The RX series clinical chemistry analysers provide laboratories with a robust and smart solution ensuring you maintain a consistent workflow and can provide accurate results first time, every time. Offering excellent customer support services, our trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument.Our world-famous test menu of high quality reagents ensures excellence in patient care, guaranteeing unrivalled precision and accuracy reducing costly test re-runs or misdiagnosis and offering complete confidence in results.
For more information visit: https://www.randox.com/clinical-chemistry-analysers/
How Randox is helping to diagnose metabolic conditions
Metabolic health is a term used to describe a collection of required chemical reactions that take place in all living organisms. A metabolic disorder develops when an abnormal chemical reaction occurs which alters the normal metabolic process.
A common misconception surrounding metabolic health is that it refers solely to your weight, and if you are overweight you are considered to be unhealthy. But in actual fact this may not be entirely true. Good metabolism means that your body is in good overall health, which doesn’t account for just your weight! Common metabolic disorders include genetic metabolic disorders, diabetes and metabolic syndrome. Understanding and testing to see how well your metabolism is functioning is key to ensuring long lasting health.
Genetics
There are a number of genetic metabolic disorders caused by mutations of single genes. Examples of common disorders include Gaucher’s disease, hemochromatosis and cystic fibrosis. Gaucher’s disease is a genetic disorder that affects the body’s ability to break down fat that can accumulate in the liver/spleen and bone marrow. Hemochromatosis is a condition that is caused by the over-absorption and build-up of iron while cystic fibrosis is a metabolic disorder that appears as a result of a build-up of mucus in lungs/liver and intestines. Each of these metabolic disorders affect certain organs from functioning properly and therefore your overall healthiness.
Diabetes
Type 2 diabetes is one of the most common types of metabolic disorders in the world that is expected to affect 592 million people by 2035. It is characterised by high blood sugar, insulin resistance or a lack of insulin being produced by the pancreas. Insulin resistance occurs when the body isn’t able to use insulin the right way which increases blood glucose levels. Insulin is needed for cells to take in glucose (sugar) from the bloodstream and convert it into energy. Over time this lack of insulin can damage the organs in your body.
Metabolic Syndrome
Metabolic syndrome (also known as syndrome X, Reaven’s syndrome, and CHAOS) is not a disease but a collection of risk factors that affect your health; these include high blood pressure, high blood sugar/cholesterol and abdominal fat. Left untreated, these risk factors, together, can lead to long term serious problems including an increased risk of heart disease, stroke and developing type 2 diabetes.
Can you improve your metabolic health?
Yes! The good news is that if you discover that your metabolic health is not up to scratch you can improve it through a combination of diet, exercise and lifestyle adjustments such as:
- 30 minutes of moderate to intense exercise 5-7 times a week
- Low-dose aspirin to reduce your risk of stroke or heart attack
- Quit smoking
- Medication for blood pressure/cholesterol/ blood sugar
- Limit alcohol intake
- Eat a healthy balanced diet
Related Products
Randox has developed the RX series of clinical chemistry analysers for superior semi-automated and fully automated testing. The RX series extensive dedicated test menu goes beyond routine testing and has many unique and high-performance tests available. Our range of tests covers several parameters to assess your overall metabolic health.
Metabolic Health Profile
| Albumin | Chloride | Potassium |
| Alkaline Phosphatase | C02 Total | Sodium |
| ALT | Creatinine | Total Bilirubin |
| AST (GOT) | Glucose | Total Protein |
| Direct Bilirubin | Lactate | Urea |
| Calcium |
The RX series clinical chemistry analysers provide laboratories with a robust and smart solution ensuring you maintain a consistent workflow and can provide accurate results first time, every time. Offering excellent customer support services, our trained engineers are on hand to work with you in preserving the continuity of your operations while maximising the potential of your RX series instrument. Our world-famous test menu of high quality reagents ensures excellence in patient care, guaranteeing unrivalled precision and accuracy reducing costly test re-runs or misdiagnosis and offering complete confidence in results.
For more information visit: https://www.randox.com/clinical-chemistry-analysers/
This Christmas, treat your laboratory to the “gift” of Randox Quality Control
At Christmas time all around the globe, people search for the best gift for their loved ones, something they will really like. At Randox Quality Control, we understand you care for your patients, and your laboratory. This year, show how much you care by treating your lab to a Randox Quality Control.
With over 35 years’ experience in the market, Quality Control is our passion and streamlining QC practice is our forte! Our extensive product offering comprises true third party controls, interlaboratory data management, external quality assessment and calibration verification.
Last year we looked in depth at Acusera – our range of true third party controls. This year, lets add another product to the Christmas wish list in the form of RIQAS, the world’s largest EQA scheme. Don’t wait until Christmas to wake up to a RIQAS programme under your tree – enrol in one of our comprehensive programmes today.
With over 45,000 laboratory participants across 133 countries, our RIQAS portfolio spans 32 comprehensive programmes ranging from Chemistry to Immunoassay, Lipids to Cardiac, Drugs to Serology and much more!
User-friendly, one page per parameter reports are available within 72 hours of the submission deadline. These reports enable at-a-glance performance assessment, ultimately allowing your laboratory to save valuable time. You will also gain access to complimentary multi-instrument and inter-laboratory reports as well as an end-of-cycle report summarising laboratory performance for each cycle and helping to identify progress over time.
Consolidation is key – and with an extensive parameter index available (up to 360 parameters) RIQAS will help you to significantly reduce costs, time and the number of individual programmes required to cover your test menu.
All RIQAS samples are free from interfering preservatives ensuring a commutable matrix that reacts to the test system in the same manner as a patient sample.
Additionally, enrolling in RIQAS isn’t just enrolling in an EQA scheme. Our programmes are accepted by National and International accreditation bodies worldwide and at the end of each cycle, participation in the scheme results in a certificate that can be used to decorate your laboratory all year around – not just at Christmas!
So this Christmas don’t give your laboratory second best, choose RIQAS, and reap the rewards.
To find out more on any of our RIQAS programmes visit our website – https://www.randox.com/riqas-external-quality-assessment/ or email us at acusera@randox.com
Randox Quality Control wish you all Season’s Greetings & a Prosperous New Year!
Meeting ISO 15189:2012 Requirements for Multiple Instruments
Approximately 70% of clinical decisions are based on laboratory test results. Poor laboratory quality can result in unreliable test results ultimately leading to misdiagnosis, inappropriate treatment and may even impact the overall quality of life for the patient. Having multiple instruments can often add to the difficulties faced in labs. The importance of quality medical services is recognised globally with several bodies existing internationally including ISO (International Organisation for Standardisation) who have developed a set of guidelines and quality systems to ensure reliable test results – ISO 15189:2012.
About ISO 15189:2012
ISO 15189:2012 was designed to outline the “requirements for competence and quality that are particular to medical laboratories”. Laboratory competence and quality are critical in patient diagnosis and care to ensure they meet the need of the clinicians & patients. Gaining accreditation to ISO 15189:2012 will assure clinicians employing your services that they will be benefitting from accurate results which have been measured against a consistent standard. You could benefit too from cost savings and enhanced end-user satisfaction.
Gaining Accreditation
ISO 15189:2012 divides the quality requirements of the laboratory into two distinct areas; Internal Quality Control (IQC) and External Quality Assessment (EQA). By combining both you can comprehensively review and monitor the overall performance of your laboratory, including personnel, equipment, and procedures.
A particular requirement of ISO 15189:2012 is:
“Laboratories accredited according to ISO 15189 that have two or more analysers for examinations, should have a defined mechanism for comparison of results across analysers”
How Randox can help labs with multiple instruments?
Randox offers solutions in both IQC and EQA to help your lab meet the ISO 15189 requirements.
RIQAS
Our international EQA scheme is the largest in the world with 45,000 participants in 133 countries.
Multi-Instrument Reports
All RIQAS participants can register up to five separate instruments per programme at no extra cost. Individual reports for each instrument plus a unique multi-instrument report are provided. The multi-instrument report plots the performance of each individual instrument on a single, colour coded Levey-Jennings chart, ensuring instant identification of any differences in instrument performance. Additional sample packs may be ordered as required.
The multi-instrument report includes many of the same statistical features found in the main RIQAS report including; CV%, SDI, RMSDI, %DEV, RM%DEV, Target Score, and RM Target Score.
Acusera 24.7 Live Online
Our stress free QC analysis software is designed to assist in the management of daily QC activities.
Support for multiple instruments
Acusera 24.7 Live Online allows laboratories to conveniently combine multiple instruments as well as analytes and QC lots on a single Levey-Jennings chart, allowing comparative performance assessment and immediate visualisation of any ongoing or emerging trends.
Helping you get accredited
Randox helps you get accredited by offering products from the full spectrum of Quality Control, meaning you never have to look elsewhere. Not all manufactures can offer these features.
To find out more about how we can help you meet ISO 15189 requirements, contact us using the form below.
Mythbusting: ‘Using IQC and EQA From the Same Provider Leads to QC Bias’
Some laboratory professionals believe that using Internal Quality Control (IQC) and External Quality Assurance (EQA, also known as Proficiency Testing) material from the same provider can lead to increased levels of qc bias, or that their test system will not be appropriately challenged. It is important to address these concerns, because some labs may in fact be hindering their own performance by using IQC and EQA material from different sources.
It is important to first understand how IQC and EQA work together to help form a complete Laboratory Quality Management System.
IQC and EQA in Laboratory Quality Management
IQC is a means of monitoring test system precision on a daily basis. IQC effectively evaluates test system performance over time, so that any sudden or gradual shifts in performance can be detected. However, while IQC is an effective performance monitor, it cannot detect more intricate problems like calibration errors or wide acceptable limits provided by some QC manufacturers.
EQA is essential for challenging test system accuracy, and is carried out less frequently than IQC testing. EQA samples are tested ‘blind’ and the results are returned to the scheme organiser. As EQA testing compares an individual lab’s performance to other labs using the same method and instrument, it is a very effective tool for identification of potential issues.
Is there any disadvantage to using IQC and EQA material from the same provider?
The answer to this question depends primarily on the source material of the IQC and EQA. If an IQC provider manufactures their material using artificial additives or components of animal origin, then it will not be suitable to use EQA material from the same provider. Westgard (2011) maintains that using non-commutable IQC or EQA material can lead to results becoming compromised due to matrix effects – something which would not happen using commutable controls.
For example, with Immunoassay testing, non-human components of IQC material interact with antibodies in the reagent in a different way to fully human patient samples – ultimately giving unpredictable shifts, and not adhering to the ISO 15189 requirement to: “use quality control materials that react to the examining system in a manner as close as possible to patient samples”.
However, if the IQC and EQA material is manufactured using a source material which is similar in composition to patient samples (100% human), this commutable control will adequately mimic patient sample performance; meaning labs can use EQA and IQC material from the same provider with confidence that the integrity of their results is maintained.
Conclusion
ISO 15189 also states: “Use of independent third party control materials should be considered…”. In this instance, ‘Independent’ does not mean from a separate provider. It means that the QC material should not be optimized for use on one specific instrument (i.e. not dependent on a single instrument/method type).
No regulatory body states a requirement to use different providers for IQC and EQA material. Indeed, using IQC from one provider and EQA from another provider could increase the risk of labs using non-commutable material.
Labs should use commutable IQC and EQA material for a true assessment of their test system. Randox QC and RIQAS EQA are specifically designed with commutability in mind, giving labs a control which reflects patient sample performance and ensures excellent performance.
How can we help?
To learn how Randox can offer a complete solution for your laboratory, follow the links below or submit a question using the form above.
References
Westgard, S. (2011). Is QC Quality Compromised?. Available: https://www.westgard.com/qc-quality-compromised.htm. Last accessed 31st October 2017.
Got a question?
Westgard’s Great Global QC Survey 2017
In a QC survey conducted this year, Sten Westgard reached out to more than 45,000 laboratory professionals to gain a comprehensive view of the world’s Quality Control practices. It was one of the largest surveys that have been conducted and shared publicly.
Read on as we take a summarised look at our favourite bits.
Setting control Limits
Most labs are using their actual performance to set their mean and SD, however, a large percentage of labs still use manufacturer’s ranges, peer group ranges, and other non-individual sources for SD. These ranges can typically be set wider than they would if the ranges were based on their actual mean and SD. This can result in labs releasing incorrect patient results.
Laboratories were asked if they used 2 SD control limits on all tests and it was found that a majority use 2 SD. The strict use of 2 SD can generate a high level of false rejections (9% for two controls and higher for three). This causes a high level of out-of-control events; the use of QC multi-rules is recommended.
The types of Controls used by labs
More than 60% of labs were found to be using manufacturer controls, the drawbacks of which are well known. The latest ISO standards strongly encourage the use of independent / third-party controls. Westgard speculates that this will become a mandatory requirement in the next version of ISO 15189.
Frequency of QC
The first question about frequency asked how often labs ran QC during a run. Respondents reported how often they schedule QC in their labs. Around half only run QC at the beginning of a run with labs running it throughout the day coming in close second. A small proportion of labs reported running QC at both the beginning and the end of a run.
The final, least popular option involves spacing out QC based on test volume, the most scientific method determining how many patient samples can be run between controls without raising the risk of unacceptable results.
The next question asked about the overall frequency of QC. Most labs are meeting the once-a-day minimum standard for CLIA regulations.
“QC frequency remains primarily based on the rotational speed of the earth, not driven by needs of the clinician and patient.” – Sten Westgard
QC Frequency Influences
Regulator and accreditation requirements lead the way in influencing the frequency of QC with manufacturer recommendations, and professional judgement following close behind. Only a quarter of labs use the volume of testing to guide their QC frequency and one in six look to EP23 or IQCP for guidance.
Managing QC
Most labs are using on-board instrument informatics to support their QC charting, followed by LIS charting programs, and peer group software.
Of significance is the number of labs using Excel spreadsheets as their primary QC tool as well as standalone QC programs or even manual graph paper. This could be due to varying technological capabilities where some locations may not have access to, or the funds to afford, informatics.
A combined third of labs are out-of-control every day. In some labs this could be the result of running such a high volume of controls that false rejections are inevitable. However, rationalising in this way can lead to ‘alert fatigue’, where users begin to ignore alert flags and stop troubleshooting.
More than a quarter of labs have an out-of-control flag every few days while another roughly one in six have just one per week. A small number of labs report having few QC flags.
Managing QC Costs
Finally, laboratories were asked about the steps they take to manage QC costs. 60% claimed that they take no steps to manage costs. One in six reduced QC frequency, one in eight switched to cheaper controls, while, worryingly, almost one in ten changed their QC rules or widened limits.
Conclusion
Westgard’s Global QC Survey suggests there exists many inefficient implementations of Quality Control, with plenty of room for improvement. The current state of QC is, like many aspects of healthcare, unsustainable. Labs must adopt better approaches or risk their continuing feasibility, or worse, their patient’s results.
How Randox Can Help
Westgard highlights particular issues with labs mismanaging costs, still using manufacturer controls, and setting control limits – this is where Randox comes in.
Acusera Third Party Controls offer the highest quality solution for any lab – regardless of size or budget. Designed to provide an unbiased, independent assessment of performance, our internal quality controls have not been manufactured in line with, or optimised for use with any particular reagent, method or instrument helping you to easily meet ISO 15189 recommendations. Unrivaled consolidation allows for significant cost savings.
Acusera 24•7 Live Online allows you to automatically apply multi-rules and generate charts to help with setting accurate control limits, helping you get your quality control under control.
Reference: Westgard, S (2017), The 2017 Great Global QC Survey Results
To learn more about how Randox Quality Control can help you improve your QC visit the pages below or fill out the contact form and someone will be in touch.